(90 days)
Not Found
No
The description focuses on "post-hoc statistical analysis" and comparing patient data to a "normative database" using "Z-Scores". While algorithms are mentioned, there is no indication of learning or adaptive capabilities characteristic of AI/ML. The performance studies describe statistical tests for normality and poolability, not AI/ML model performance metrics.
No
The device is described as a platform for the "post-hoc statistical analysis of the human electroencephalogram" and its output is "intended to be used by clinicians to enable the evaluation of the patient's brain activity." It analyzes data and compiles reports, but it does not directly treat or provide therapy to patients.
Yes
The device performs "post-hoc statistical analysis of the human electroencephalogram" and provides reports "intended to be used by clinicians to enable the evaluation of the patient's brain activity". This processing and evaluation of patient data for clinical assessment aligns with the definition of a diagnostic device.
Yes
The device is described as a "Platform" consisting of software algorithms, a report generator, and data transfer/storage functionality, which processes data from a separate, commercially available, and FDA-cleared EEG system. It does not include the EEG hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BNA™ Platform analyzes electroencephalogram (EEG) data, which is a measurement of electrical activity in the brain. This data is collected externally from the body, not from a biological sample taken from the body.
- Intended Use: The intended use is for the post-hoc statistical analysis of EEG data to evaluate brain activity. This is a neurological assessment, not a diagnostic test performed on a biological sample.
Therefore, while this device is a medical device used for analysis, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs').
This device is indicated for use in individuals 12 to 85 years of age.
The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.
Product codes (comma separated list FDA assigned to the subject device)
OLU
Device Description
The BNATM Platform is intended for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing both resting-state EEG and Event-Related Potentials ("ERP") in a patient's response to outside stimuli during various states of alertness, disease, diagnostic testing, treatment, surgery, or drug related dysfunction. An Event-Related Potential (or "evoked response") is an electrical potential recorded from the nervous system following the presentation of a stimulus (e.g., as part of a cognitive task). An ERP signal consists of typical ERP components - positive or negative voltage spatiotemporal peaks within the ERP waveform that are measured within one second post-stimulus presentation. The BNATM Platform is intended to analyze EEG data recorded at rest and during the performance of two conventionally used ERP tasks, the Auditory Oddball (AOB) and the Visual Go No-Go (VGNG).
The EEG is recorded continuously while the patient is at rest with eyes-closed (hereby Eyes-Closed) or performs one of the ERP tasks (hereby ERP tasks). The acquisition site is asked to provide reliable samples of artifact-free digital EEG for purposes of analysis. After the recording, the artifact-free EEG data is imported into the BNATM Platform and is automatically analyzed by the algorithm and the results of the processed data are compiled into individualized Reports:
- ERP Report
- Behavioral Report
- Summary Report
- Resting-State EEG Report
Scores are presented as Z-Scores based on comparing the patient to an age-matched relevant reference group based on elminda's normative database. This presentation expresses the differences between the patient and the reference group.
The BNA™ Reports are intended to be used by clinicians to enable the evaluation of the patient's brain activity during a specific task compared to an age-range matched reference group.
The system consists of the following components: a computer environment; EEG data input software algorithms for BNA™ calculations; a report generator and a functionality for data transfer and storage.
The device processes and analyzes data received from a dedicated, commercially available, and FDA cleared EEG system, which complies with the BNATM Platform specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electroencephalogram ("EEG")
Anatomical Site
Brain/head
Indicated Patient Age Range
12 to 85 years of age.
For Visual Go No-Go (VGNG) task: 25 to 85 years.
Intended User / Care Setting
Used by a Clinician / Prescription device.
Description of the training set, sample size, data source, and annotation protocol
Not Found (Refers to "Reference-Group Database" for normative data rather than a training set with annotation protocol.)
Description of the test set, sample size, data source, and annotation protocol
The objective of the clinical study was to establish and validate the Reference-Group Database and to evaluate its test-retest reliability.
Healthy volunteers aged 12-85 years old were recruited from 13 clinical sites, with 12 sites located within the US. Depending on the site's protocol, the volunteers either participated at a single visit, or at two successive visits, separated by approximately 1 week to provide data for the re-test database. Brain electrophysiological activity was collected using the BNA 100 Platform while the participants performed the Eyes-Closed (EC) task and one or more cognitive task, including the Auditory Oddball (AOB) task (using the hearing adjusted version for participants older than 50 years) and the Visual Go-No-Go (VGNG) task.
The Reference-Group Database for the AOB and VGNG tasks is divided into the following age groups: 25-35, 35-50, 50-65, 65-75, and 75-85 years for VGNG, and 12-14, 14-16, 16-18, 18-25, 25-35, 35-50, 50-65, 65-75, and 75-85 years for AOB. For the Resting-EEG, reference groups were created at 0.5-year resolution by taking 133 overlapping bins covering the range 12-85.
The normative database includes:
- 1900 subjects covering the age-range 12-85 for the AOB task.
- 1407 subjects covering the age-range 12-85 for the Eyes-Closed Resting-State EEG.
- 1005 subjects covering the age-range 25-85 for the VGNG task.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study: The objective of the clinical study was to establish and validate the Reference-Group Database and to evaluate its test-retest reliability.
Sample Size: Healthy volunteers aged 12-85 years old were recruited from 13 clinical sites. (Specific sample size for the overall study is not explicitly stated, but the database sizes are listed: 1900 for AOB, 1407 for Eyes-Closed Resting-State EEG, 1005 for VGNG).
Key Results:
- Normality Testing: EEG/ERP scores were transformed and validated for their normal distribution by using four normality tests: Anderson-Darling, Cramer-von Mises, Kolmogorov-Smirnov, and Shapiro-Wilk. A score was considered normally distributed if at least 2 of the four tests were not statistically significant (p-value > 0.05). Normality of the EEG Scores was also tested using a Gaussian leave-one-out sensitivity test. All Resting-EEG and ERP scores passed the 'two out of four' method tests with a success rate above 97% and 98%, respectively. Resting-EEG scores also passed the Gaussian leave-one-out sensitivity tests with a success rate larger than 97.5%. These results are in accordance with the success rates presented in the predicate device statistical performance and allow for an accurate clinical interpretation of z-scores.
- Poolability Testing: Poolability of the Reference Group data was tested with a linear regression model for each combination of ERP score or behavioral performance score and age-bin and checked for cases with a significant age-effect (p
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
elminda, Ltd % Donna-Bea Tillman Senior Consultant Biologics Consulting 1555 King Street. Suite 300 Alexandria, Virginia 22314
Re: K202588
Trade/Device Name: BNA Platform Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: September 4, 2020 Received: September 8, 2020
Dear Donna-Bea Tillman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202588
Device Name BNA™ Platform
Indications for Use (Describe)
The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs').
This device is indicated for use in individuals 12 to 85 years of age.
The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------- |
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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the BNA™ Platform is provided below.
1. SUBMITTER
| Applicant: | elminda Ltd. |
|---|---|
| 1 Arie Shenkar Street | |
| Herzliya, 4672501, Israel | |
| Contact: | Keren Elghouzzi-Kazachinsky |
| QA/RA Manager | |
| Elminda | |
| +972-53 7739780 | |
| quality@elminda.com | |
| Submission Correspondent: | Donna-Bea Tillman, Ph.D. |
| Senior Consultant | |
| Biologics Consulting | |
| 1555 King St, Suite 300 | |
| Alexandria, VA 22314 | |
| 410-531-6542 | |
| dtillman@biologicsconsulting.com | |
| Date Prepared: | December 3, 2020 |
2. DEVICE
| Device Trade Name: | BNA™ Platform |
|---|---|
| Device Common Name: | Normalizing Quantitative Electroencephalograph |
| Software | |
| Classification Name: | 21 CFR 882.1400 Electroencephalograph, |
| Regulatory Class: | II |
| Product Code: | OLU |
PREDICATE DEVICE 3.
| Predicate Device: | K121119 - BNA™ Analysis System (Elminda) |
|---|---|
| Secondary Predicate Device: | K171414 - qEEG-Pro (BrainMasters Technologies, Inc) |
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DEVICE DESCRIPTION 4.
The BNATM Platform is intended for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing both resting-state EEG and Event-Related Potentials ("ERP") in a patient's response to outside stimuli during various states of alertness, disease, diagnostic testing, treatment, surgery, or drug related dysfunction. An Event-Related Potential (or "evoked response") is an electrical potential recorded from the nervous system following the presentation of a stimulus (e.g., as part of a cognitive task). An ERP signal consists of typical ERP components - positive or negative voltage spatiotemporal peaks within the ERP waveform that are measured within one second post-stimulus presentation. The BNATM Platform is intended to analyze EEG data recorded at rest and during the performance of two conventionally used ERP tasks, the Auditory Oddball (AOB) and the Visual Go No-Go (VGNG).
The EEG is recorded continuously while the patient is at rest with eyes-closed (hereby Eyes-Closed) or performs one of the ERP tasks (hereby ERP tasks). The acquisition site is asked to provide reliable samples of artifact-free digital EEG for purposes of analysis. After the recording, the artifact-free EEG data is imported into the BNATM Platform and is automatically analyzed by the algorithm and the results of the processed data are compiled into individualized Reports:
- . ERP Report
- Behavioral Report ●
- . Summary Report
- Resting-State EEG Report ●
Scores are presented as Z-Scores based on comparing the patient to an age-matched relevant reference group based on elminda's normative database. This presentation expresses the differences between the patient and the reference group.
The BNA™ Reports are intended to be used by clinicians to enable the evaluation of the patient's brain activity during a specific task compared to an age-range matched reference group.
The system consists of the following components: a computer environment; EEG data input software algorithms for BNA™ calculations; a report generator and a functionality for data transfer and storage.
The device processes and analyzes data received from a dedicated, commercially available, and FDA cleared EEG system, which complies with the BNATM Platform specifications.
5. INTENDED USE/INDICATIONS FOR USE
The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs").
This device is indicated for use in individuals 12 to 85 years of age.
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The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.
6. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
The subject device and the two predicate devices all have the same intended use, namely, to provide analyses of human EEG data. The features of the subject device have been expanded from those of the primary predicate BNA device to include additional age ranges and tasks, similar to the capabilities of the predicate qEEG-Pro device. The differences in the wording of the Indications for use reflect this expansion in features as well as a minor modification to reflect a change to the currently accepted terminology of "event-related potentials" as opposed to "evoked response potentials". These differences do not impact the intended use, and therefore the subject device has the same intended use as the predicate device.
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate device K121119 - BNATM Analysis System (K121119) and qEEG-Pro (K171414).
| | BNA™ Platform | BNA™ Analysis
System | qEEG-Pro | Discussion |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | |
| Manufacturer | elminda | elminda | BrainMasters
Technologies, Inc | N/A |
| 510k Number | N/A | K121119 | K171414 | N/A |
| Product Code | OLU | OLU | OLU | Same as Predicate |
| Intended
patient
population | 12-85 years (for AOB
and Eyes closed tasks)
25-85 years (for VGNG) | 14-24 years | 4-82 years | Extended age range;
Clinical data
demonstrates equivalent
performance. |
| Tasks | AOB, VGNG, and Eyes-
Closed Resting-State | Auditory Oddball
(AOB) | Eyes-Closed and
Eyes-Open Resting-
State | Additional Tasks:
VGNG and
Resting-State EEG;
clinical testing
demonstrates equivalent
in safety and
effectiveness. |
| Intended User | Used by a Clinician /
Prescription device | Used by a Clinician /
Prescription device | Used by a Clinician
/ Prescription device | Same as predicate |
| | BNA™ Platform | BNA™ Analysis
System | qEEG-Pro | Discussion |
| | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | |
| Band Passing
(ERP) | Frequency
decomposition of the
EEG data into: Delta,
Theta and Alpha
frequency bands. | Frequency
decomposition of the
EEG data into: Delta,
Theta and Alpha
frequency bands | Not relevant - does
not cover ERP
functions | Same as Predicate |
| Time-
Analysis
(ERP) | A time domain peak
analysis is performed | A time domain peak
analysis is performed | Not relevant (ERP
only) | Same as predicate |
| Analysis of
Band-passed
(ERP) | Peak analysis is applied
for the individual band-
passed time-series (i.e.,
peak analysis for Alpha,
Delta, Theta) | Peak analysis is applied
for the individual band-
passed time-series (i.e.,
peak analysis for Alpha,
Delta, Theta) | Not relevant (ERP
only) | Same as Predicate |
| Peak
Analysis
(ERP) | Peak-detection at the
level of the decomposed
ERP (post frequency
decomposition) is
performed for each
electrode separately
followed by selection of
the highest peak. | Peak-detection at the
level of the
decomposed ERP
(post frequency
decomposition) is
performed for each
electrode separately in a
specific time and space
range | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. The
results of poolability
and normality
performance validation
test demonstrated
equivalence to the
success rate of
predicate and do not
raise new issue of
safety and effectiveness |
| Neural-
Consistency | The algorithm calculates
a new score – 'Neural
Consistency' based on
the similarity of the
amplitude activation
between single-ERP
trials | No; new score | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. The
results of poolability
and normality
performance validation
test demonstrated
equivalence to the
success rate of
predicate and do not
raise new issue of
safety and effectiveness |
| Reported
ERP peaks | The highest ERP peaks
within literature-based
time constraints, which
show the highest spatio-
temporal similarity to the | The ERP peaks at
network-based, pre-
defined electrodes
appear in the report | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. The
results of poolability
and normality
performance validation
test demonstrated
equivalence to the
success rate of |
| | BNATM Platform | BNATM Analysis
System | qEEG-Pro | Discussion |
| | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | |
| | group ERP appear in the
report | | | equivalence to the
success rate of
predicate and do not
raise new issue of
safety and effectiveness |
| Network
Analysis | No network analysis | Network analysis based
on the ERP-peaks as
the network nodes | Not relevant (ERP
only) | Feature removed |
| Topographica
l maps of
ERP | Subject ERP-peak
position is displayed on a
topographical map
together with the group
ERP-peak position. | Z-scores are presented
as topographical-maps
(electrode coordinates).
Networks activity over
time is presented in
time evolution maps | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. The
results of poolability
and normality
performance validation
test demonstrated
equivalence to the
success rate of
predicate and do not
raise new issue of
safety and effectiveness |
| ERP
Waveforms | Broadband (0.5-30Hz)
and band-pass (Delta,
Theta and Alpha) ERP
waveforms of the subject
are visualized in
comparison to the
averaged ERP waveform
of the age-matched
reference group. | Broadband (0.5-30Hz)
ERP waveforms of the
subject are visualized in
comparison to the
averaged ERP
waveform of the age-
matched reference
group. | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. The
results of poolability
and normality
performance validation
test demonstrated
equivalence to the
success rate of
predicate and do not
raise new issue of
safety and effectiveness |
| ERP
waveforms
display by
stimulus type | The ERP waveform
display is divided into
sections by stimulus type | The ERP waveform
display is divided into
sections by stimulus
type | Not relevant (ERP
only) | Same as Predicate |
| Display of
representative
ERPs | Within each stimulus-
section, 19 panels
represent 19 selected
electrode locations on
the scalp. These are
electrode positions
described in the
international 10-20 | Within each stimulus-
section 20 panels
represent 20 selected
electrode locations on
the scalp. These are
electrode positions
described in the
international 10-20 | Not relevant (ERP
only) | Performance testing
demonstrates correct
implementation. |
| | BNA™ Platform | BNA™ Analysis System | qEEG-Pro | Discussion |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | |
| | system of electrode placement. | system of electrode placement. | | |
| Comparison to Normative Database | Yes; 1900 and 1407 subjects covering the age-range 12-85 for the tasks AOB and Eyes-Closed Resting-State EEG, respectively. In addition, 1005 subjects covering the age-range 25-85 for the VGNG task | Yes; 120 subjects in the age-range 14-24 AOB task only | Yes: Z-scores are calculated based on reference-group mean and std. (Not for ERP) | Reference database expanded to include additional subjects; performance testing demonstrates validity of revised database |
| Resting-State EEG data Comparison against the Normative Database | Yes; 1407 subjects covering the age-range 12-85 for Eyes-Closed Resting-state EEG | No | Yes; 1482 samples (eyes-closed); 1231 subjects (eyes-open) | Clinical data demonstrates equivalent performance |
| Resting-State EEG Spectral-Analysis | Yes; 4 frequency bands (delta, theta, alpha, and beta) | No | Yes; 4 frequency bands (delta, theta, alpha, and beta) | Same as predicate |
| Spectral Analysis scores | Yes, the following scores are extracted from PSD: Average Absolute Power, Relative Power, Individual Alpha Frequency, Hemispheric Asymmetry and Frequency Ratios | No | Yes; The following scores are extracted from PSD: Absolute Power, Relative Power, Alpha Peak Frequency, Hemispheric Asymmetry, Coherence and Frequency Ratios | The Average Absolute Power score is well-known in the scientific literature and was statistically validated for normality. |
| Age Range Included in the Normative Database | 12-85 years | 14-24 years | 4-82 years | The existing normative database has been extended to include additional age-ranges. The additional age-bins and tasks were clinically validated. |
| | BNA™ Platform | BNA™ Analysis
System | qEEG-Pro | Discussion |
| | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | |
| Visual
Display of
EEG | Yes: topographical maps of Average Absolute and Relative Power, Individual Alpha Frequency, Hemispheric Asymmetry and Frequency Ratios | No | Yes: topographical maps of Absolute and Relative Power, Power Asymmetry, and Coherence for 19 monopolar and 171 selected bipolar derivations of the EEG | The features are equivalent and the results of performance testing demonstrate equivalent performance |
| Hardware | Runs on the AWS cloud and accepts EEG data from all sites | Standalone computer running the BNA™ engine locally and contains the EEG/ERP data locally | | The results of System and Software Test Verification demonstrate that the subject device meets the defined requirements |
Table 1: Technological Comparison
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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness and the BNA™ Platform can be found substantially equivalent to the predicate devices.
7. PERFORMANCE DATA
Biocompatibility Testing
BNA™ Platform is a software only device. There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.
Sterilization and Shelf Life
BNA™ Platform is a software only device. Therefore, sterilization and shelf life are not applicable.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. BNA™ Platform is a software only device. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this
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device was considered as a moderate level of concern. Testing was conducted to ensure the product works as designed and to validate the performance of the device.
Bench Testing
Not applicable. Bench testing was not necessary to establish the substantial equivalence of this device.
Animal Testing
Not applicable. Animal studies were not necessary to establish the substantial equivalence of this device.
Clinical Data
The objective of the clinical study was to establish and validate the Reference-Group Database and to evaluate its test-retest reliability.
Healthy volunteers aged 12-85 years old were recruited from 13 clinical sites, with 12 sites located within the US. Depending on the site's protocol, the volunteers either participated at a single visit, or at two successive visits, separated by approximately 1 week to provide data for the re-test database. Brain electrophysiological activity was collected using the BNA 100 Platform while the participants performed the Eyes-Closed (EC) task and one or more cognitive task, including the Auditory Oddball (AOB) task (using the hearing adjusted version for participants older than 50 years) and the Visual Go-No-Go (VGNG) task.
The Reference-Group Database for the AOB and VGNG tasks is divided into the following age groups: 25-35, 35-50, 50-65, 65-75, and 75-85 years for VGNG, and 12-14, 14-16, 16-18, 18-25, 25-35, 35-50, 50-65, 65-75, and 75-85 years for AOB. For the Resting-EEG, reference groups were created at 0.5-year resolution by taking 133 overlapping bins covering the range 12-85.
EEG/ERP scores were transformed and validated for their normal distribution by using the same methodology in accordance with the predicate device: using four normality tests Anderson-Darling, the Cramer-von Mises, the Kolmogorov-Smirnov, and the Shapiro-Wilk tests. A score was considered to be normally distributed if at least 2 of the four tests were not statistically significant (p-value > 0.05) Normality of the EEG Scores was also tested using a Gaussian leaveone-out sensitivity test.
The normality test results are in accordance with the success rates presented in the predicate device statistical performance and, from a clinical perspective, allow for an accurate clinical interpretation of z-scores.
All Resting-EEG and ERP scores pass the 'two out of four' method tests (i.e., passing at least 2 out of 4 different normality tests) with a success rate above 97% and 98%, respectively, with Resting-EEG scores also passing the Gaussian leave-one-out sensitivity tests with a success rate larger than 97.5% an acceptable percentage of failures, given the large number of scores tested. These results are in accordance with the success rates presented in the predicate device statistical performance and allow for an accurate clinical interpretation of z-scores.
Poolability of the Reference Group data was tested with a linear regression model for each combination of ERP score or behavioral performance score and age-bin and checked for cases
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with a significant age-effect (p